Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
The primary objectives of this study are to compare the immune response of Fluzone HD, a
high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children
with cancer and in children with HIV.
The secondary objectives of this study are to:
- Describe the safety and reactogenicity of high-dose and standard-dose TIV.
- Compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and
- Describe the relationship between baseline lymphocyte numbers/function and
robustness/durability of the immune response.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of sero-conversion
Compare the immune responses of Fluzone HD to Fluzone in children with cancer or HIV. This is an open label, randomized study in two groups of patients.
2 months after initial vaccine
Jonathan A McCullers, MD
St. Jude Children's Research Hospital
United States: Food and Drug Administration
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|